Summary:
Perform routine synthesis, labeling, purification and QC of a wide variety of chemicals and biologicals, that may include amino acids, proteins, nucleotides, nucleosides, ligands and other chemicals. May use a combination of synthetic, enzymatic or cell culture techniques and basic synthetic, analytical, functional assay, and laboratory skills. Independently provides solutions to a variety of problems of moderate scope and complexity.
Core Duties and Responsibilities:
Execute product manufacturing according to established procedures, record the data, interpret results and validate the quality of the data.
Independently trouble-shoot and resolve problems.
Support general lab functions, setup, calibration and maintenance of equipment.
Production records and test data will be reviewed by supervisor or designee.
Produce products under Quality standards ISO 9001, ISO 14001, ISO 18001 and Class A manufacturing principles.
Perform quality control test to ensure quality of raw material and finished product.
Work safely and in compliance with all applicable company, federal and local regulations.
Additional Responsibilities:
Chemistry may be performed with radioactivity, hazardous chemicals, or biological. Chemist must have adequate training to handle these chemicals and work safely under laboratory rules and SOPs.
May include participation in procedure drafting, revision and process improvement.
May require performing tasks following cGMP guidelines.
May require participation in inventory receipt/warehousing and control of raw materials reagents, product and lab supplies.
May include labeling, dispensing, packaging of reagents and final product.
May participate in the investigation, recording and implementation of product deviations or CAPA systems.
May participate in transfer and implementation of new products into the production lab
May perform functional assays using appropriate instrumentation.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Basic Qualifications:
Preferred Qualifications:
Should have good familiarity with applicable modern analytical tools that may include HPLC, TLC, GC, ICP, NMR, UV-Vis or similarly related equipment.
A good understanding of analytical chemistry, chemistry, biology or related scientific discipline.
Demonstrates application of specialized professional knowledge and skill.
Physical Requirements: